A Randomized, Open, Phase IV Exploratory Clinical Trial to Evaluate the Efficacy and Safety of Acupunture on the outcome of Induction of Ovulation in woman with Poor Ovarian Response
- Conditions
- Pregnancy, childbirth and the puerperium
- Registration Number
- KCT0002623
- Lead Sponsor
- Korea Institute of Oriental Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 70
1) Who have voluntarily signed a written consent to participate in the trial
2) Women whose infertility period is more than one year or who have been diagnosed with infertility in medical institutions.
3) Who have been diagnosed with a poor ovarian response (POR) within the past 3 months (included in at least two of the following criteria).
? Advaned maternal age (=40 years) or any other risk factor for POR
? A previous POR (=3 oocytes with a conventional stimulation protocol)
? An abnormal ovarian reserve test (Anti-mullerian hormone (AMH)<0.5-1.1 ng/ml or total antral follicle count <5-7 follicles)
4) Persons between the ages of 20 and 45 under the written consent day
5) Who have the ability and willingness to take the test during the clinical trial period.
1) Who can not receive acupuncture treatment for 2 months
2) Who are taking or administer medicines and procedures related to pregnancy, such as hormone, herbal medicine, and moxibustion treatment
3) Whose menstrual cycle is less than 21 days, more than 40 days, irregular
4) Azoospermia male
5) Polycystic ovary syndrome, thyroid disease, hyperprolactinemia, etc. ovulation disorder
6) Persons with physical or mental impairment who may be exposed to risk by participating in this clinical trial under test, who may cause confusion in results, or fail to comply with the requirements of the clinical trial
7) Who have a neurological or psychologically pathologic history or are currently suffering from a disease
8) Who can not be treated by acupuncture due to skin diseases such as ulcer or eczema
9) Who have participated in other clinical trials within the past 3 months
10) Who have a history of drug abuse and alcohol abuse within 5 years prior to clinical trial participation
11) Who have been diagnosed with infertility due to a deformity of the reproductive organs or leiomyoma
12) Others who are considered difficult to perform the clinical trial by the researcher
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method retrieval mature oocyte
- Secondary Outcome Measures
Name Time Method antral follicle count;anti-mullerian hormon;Depression, Anxiety and Stress Sclaes (DASS-42) score